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RECRUITING

NCT07856368

Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations

Sponsor: Psychiatric University Hospital, Zurich

View on ClinicalTrials.gov

Summary

Auditory verbal hallucinations (AVH), such as hearing voices in the absence of an external sound source, are a common and distressing symptom of schizophrenia. In some patients, hallucinations persist despite treatment with antipsychotic medication. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that may reduce auditory hallucinations by decreasing activity in brain regions involved in auditory and language processing. This randomized, double-blind, sham-controlled study will investigate whether individualized, neuronavigated inhibitory rTMS can reduce persistent auditory verbal hallucinations. Forty adults with medication-resistant auditory hallucinations will be randomly assigned to receive either active rTMS or sham stimulation. For each participant, the stimulation target in the primary auditory cortex will be individually identified using electroencephalography (EEG), acoustic evoked potentials, and magnetic resonance imaging (MRI)-based neuronavigation. Participants will receive two rTMS sessions per day for five consecutive days. The severity of auditory hallucinations will be assessed before and after treatment and at a 28-day follow-up. The study will also investigate whether treatment is associated with changes in brain activity and functional connectivity measured by EEG, including changes in the P300 event-related potential.

Official title: Functional Neuronavigated EEG and TMS-treatment of Chronic Acoustic Hallucinations

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-11

Completion Date

2028-11

Last Updated

2026-10-02

Healthy Volunteers

Conditions

Schizophrenia Auditory Verbal Hallucinations

Interventions

DEVICE

Neuronavigated repetitive transcranial magnetic stimulation (rTMS)

Individualized neuronavigated inhibitory rTMS is applied to the primary auditory cortex. The individual stimulation target is determined using EEG-based auditory evoked potentials and MRI-based neuronavigation. Stimulation is delivered at 1 Hz on five consecutive days, with a total of 12,000 magnetic pulses administered over the treatment course.

DEVICE

Sham repetitive transcranial magnetic stimulation (rTMS)

Sham stimulation is administered using the same neuronavigation procedures and treatment schedule as active rTMS. A sham coil visually and acoustically resembling the active coil is used but does not deliver active magnetic stimulation.

Inclusion Criteria: * Written informed consent provided prior to participation * Age 18 to 65 years * Medication-resistant auditory hallucinations, defined as: * At least two adequate trials of antipsychotic medication * At least one of these trials with an atypical antipsychotic medication * At least five episodes of auditory hallucinations per day during the preceding month * Stable antipsychotic medication for at least 6 weeks * Current treatment at the Psychiatric University Hospital Zurich (PUK), either in an outpatient clinic, day clinic, or inpatient ward * Sufficient knowledge of German to understand the study procedures and assessments * Ability to follow study procedures Exclusion Criteria: * Contraindications to TMS treatment, including cochlear implants, metallic devices close to the TMS coil, history of stroke, head injury, or seizures/epilepsy * History of epileptic convulsive seizures or epileptiform potentials in previous EEG examinations * TMS treatment within the 3 months preceding study inclusion * Known severe hypersensitivity or severe adverse reaction to TMS * Pregnancy or breastfeeding * Intention to become pregnant during the study * Major somatic comorbidities, such as renal failure, hepatic dysfunction, heart failure, or cardiovascular disease * Current treatment with any drug that lowers the seizure threshold * Known or suspected non-compliance, drug abuse, or alcohol abuse * Vulnerable subjects (children, pregnant women, elderly persons) * Inability to follow study procedures, for example due to language problems, psychological disorder, dementia, or other conditions interfering with participation * Participation in another study involving investigational treatment within the 30 days preceding study inclusion or during the present study * Current electroconvulsive therapy (ECT) * Previous enrollment in the present study * Investigator, family member of the investigator, employee, or other dependent person * Contraindications or limitations related to the medical device as specified in the instructions for use

Locations (1)

Psychiatric University Hospital Zurich

Zurich, Switzerland